Sunitinib Malate Before and After Surgery in Treating Patients With Previously Untreated Metastatic Kidney Cancer

NCT01024205 | Completed Phase 2

• 6 other identifiers: OCTG-SuMRCDR0000660317EUDRACT-2006-004511-21REDA-4911MREC-07/Q0603/58PFIZER-OCTG-SuMR
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib malate before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving sunitinib malate after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving sunitinib malate before and after surgery works in treating patients with metastatic kidney cancer.

Conditions

Kidney Cancer

Keywords

clear cell renal cell carcinoma; stage IV renal cell cancer

Outcome Measures

Primary Outcomes (1)

• Neoadjuvant sunitinib malate achieving a clinical benefit of ≥ 70%

Secondary Outcomes (3)

• Time to radiological progression

• Overall survival

• Proportion of patients suitable for nephrectomy after neoadjuvant sunitinib malate

Interventions

sunitinib malate DRUG

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed renal cell carcinoma * Measurable metastatic disease on CT/MRI imaging * Patients with suspicion of renal cancer on radiology must have a biopsy to confirm diagnosis of clear cell disease * No prior therapy for renal cancer * Judged by the treating physician to have the potential to derive clinical benefit from this treatment PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1 x 10\^9/L (without growth factor support) * Platelet count ≥ 75 x 10\^9/L * Total bilirubin ≤ 2 times upper limit of normal (ULN) (except for patients with Gilbert disease) * Serum creatinine ≤ 2 times ULN * Serum transaminases \< 5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 28 days after completion of study therapy * Willing and able to comply with scheduled visits, treatment plan, and laboratory tests and other study procedures * No congestive heart failure, myocardial infarction, or coronary artery bypass graft within the past 6 months, or ongoing severe or unstable arrhythmia requiring medication * No other severe acute or chronic medical or psychiatric condition, or abnormal laboratory results that would impart, in the judgement of the investigator, excess risk associated with study participation or study drug administration or would make the patient inappropriate for entry into this study PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 7 days since prior and no concurrent potent CYP3A inhibitors, including any of the following: * Ketoconazole * Itraconazole * Clarithromycin * Erythromycin * Diltiazem * Verapamil * Delavirdine * Indinavir * Saquinavir * Ritonavir * Atazanavir * Nelfinavir * At least 12 days since prior and no concurrent potent CYP3A inducers, including any of the following: * Rifampin * Rifabutin * Carbamazepine * Phenobarbital * Phenytoin * St. John's wort * Efavirenz * Tipranavir * Concurrent radiotherapy allowed provided sunitinib malate is stopped one day before and resumed one day after radiotherapy * Concurrent coumarin-derivative anticoagulants (e.g., warfarin) allowed (≤ 2 mg/day) for prophylaxis of thrombosis * No concurrent treatment with a drug having proarrhythmic potential (i.e., terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, or flecainide) * No other concurrent investigational drug or participation in another clinical trial (unless approved by the sponsor)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barts and the London School of Medicine and Dentistry: lead

Study Sites (1)

Orchid Clinical Trials Group at Barts and the London School of Medicine and Dentistry

London, England, EC1M 6BQ, United Kingdom

Location

Related Publications (4)

• Powles T, Chowdhury S, Bower M, Saunders N, Lim L, Shamash J, Sarwar N, Sadev A, Peters J, Green J, Boleti K, Augwal S. The effect of sunitinib on immune subsets in metastatic clear cell renal cancer. Urol Int. 2011;86(1):53-9. doi: 10.1159/000319498. Epub 2010 Oct 26.

  PMID: 20975250 RESULT

• Stewart GD, Powles T, Van Neste C, Meynert A, O'Mahony F, Laird A, Deforce D, Van Nieuwerburgh F, Trooskens G, Van Criekinge W, De Meyer T, Harrison DJ. Dynamic epigenetic changes to VHL occur with sunitinib in metastatic clear cell renal cancer. Oncotarget. 2016 May 3;7(18):25241-50. doi: 10.18632/oncotarget.8308.

  PMID: 27029034 DERIVED

• Stewart GD, O'Mahony FC, Laird A, Rashid S, Martin SA, Eory L, Lubbock AL, Nanda J, O'Donnell M, Mackay A, Mullen P, McNeill SA, Riddick AC, Aitchison M, Berney D, Bex A, Overton IM, Harrison DJ, Powles T. Carbonic anhydrase 9 expression increases with vascular endothelial growth factor-targeted therapy and is predictive of outcome in metastatic clear cell renal cancer. Eur Urol. 2014 Nov;66(5):956-63. doi: 10.1016/j.eururo.2014.04.007. Epub 2014 May 10.

  PMID: 24821582 DERIVED

• Shaw GL, Hussain M, Nair R, Bycroft J, Beltran L, Green JS, Powles T, Peters JL. Performing cytoreductive nephrectomy following targeted sunitinib therapy for metastatic renal cell carcinoma: a surgical perspective. Urol Int. 2012;89(1):83-8. doi: 10.1159/000338057. Epub 2012 May 16.

  PMID: 22614181 DERIVED

MeSH Terms

Conditions

Kidney Neoplasms; Carcinoma, Renal Cell

Interventions

Sunitinib; Chemotherapy, Adjuvant; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Thomas Powles, MD, MRCP

  Barts and the London School of Medicine and Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: August 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: May 1, 2012
• Last Updated: August 12, 2013

Record last verified: 2011-07

Locations

GB (1)